Kornimate/medical-research-clean huggingface dataset:
the neurobehavioral effects of anesthetics on infants with hearing impairment

Conditions: Long Term Neurobehavioral Effects

Summary: the long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. a retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. when infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. in this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.


Eligibility criteria:
inclusion criteria: 1. infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital 2. patients who have not participated in other clinical trials 3. asa class i-ii selective operation without any acute infectious diseases or systematic diseases 4. infant's family members agree to participated in the trials and sign the informed consent exclusion criteria: 1. reject to sign the informed consent and participate in the trials 2. patients with severe liver and kidney damage or other heart, lung and nervous system diseases 3. the gesell developmental scale is less than 86 in motor behavior and physical energy 4. with a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice 5. infant who is allergic to egg and milk 6. family history of malignant hyperthermia 7. allergy to anesthetic drugs

Keywords: infant anesthesia neurobehavioral development
a study to compare fcd105 foam to minocycline 3% foam, adapalene 0.3% foam and vehicle foam.

Conditions: Acne Vulgaris

Summary: a study comparing fcd105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.


Eligibility criteria:
inclusion criteria: 1. has facial acne vulgaris with all of the following: 1. 20 to 50 inflammatory lesions (papules and/or pustules) on the face. 2. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face. 3. iga score of moderate (3) to severe (4). 2. no more than two active nodules on the face. 3. willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study exclusion criteria: 1. female who is pregnant or lactating, or is planning a pregnancy during the study. 2. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations. 3. facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations. 4. sunburn on the face. 5. severe systemic disease as assessed by the investigator that might interfere with the conduct of the study or the interpretation of the results. 6. subjects who have a documented history of any of the following: 1. allergy to tetracycline-class antibiotics or to any ingredient in the study drug. 2. pseudomembranous colitis or antibiotic-associated colitis. 3. hepatitis or clinically significant liver damage or clinically significant renal impairment. 4. known or suspected premalignant or malignant disease (excluding successfully treated skin cancers). 7. subjects who have used the following medications: within 1 week prior to randomization: * medicated facial cleansers on the face. * topical acne treatments on the face (other than those listed below). within 4 weeks prior to randomization: * topical retinoids on the face. * topical anti-inflammatories and/or corticosteroids on the face. * topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. in body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days). * systemic antibiotics. * systemic acne treatments. within 12 weeks prior to randomization: * systemic retinoids. * systemic corticosteroids (note: intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose). 8. use of sauna during the 2 weeks prior to randomization. 9. epilation of the face within 2 weeks prior to randomization. 10. folliculitis on the face. 11. documented history of depression that is not, in the opinion of the investigator, currently adequately controlled with medication
comparison of mini gastric bypass and roux-en-y gastric bypass

Conditions: Morbid Obesity

Summary: this study compares roux-en-y gastric bypass with single anastomosis gastric bypass in a randomized prospective setting. this study also adresses the issue of bile reflux after mgb.

roux-en-y gastric bypass (rygb) and single anastomosis gastric bypass (sagb or mini gastric bypass, mgb) have both shown excellent weight-loss and effect on comorbidities such as type 2 diabetes. in this study eligible patients are randomized for either of the operations. effects on glucose homeostasis as well as weight-loss and the effect on comorbidities are recorded during the follow-up. before the surgery and at 6 and 12 months, all participants will undergo body composition measurements (bioimpedance, mri and dexa), mixed meal tests and oral glucose tolerance tests, calorimetry and biopsies of skin, subcutaneous fat and muscle will be obtained and samples of urine, feces and saliva are collected. at these timepoints, all patients will fill out questionnaires regarding psychocological, social and physical health and wellbeing. interim analysies will be done for the first 60 patients (30 per group) after 3 months, in which safety issues and trial setup is reviewed. if there are no problems with safety and setup, the trial can be carried out according to initial plan. at 12 months, all outcomes for all patients will be analyzed. main outcome is weight-loss one year after the surgery. follow-up continues at 24months, 5 years and 10 years after the surgery and follow-up data will be analyzed accordingly. also, mgb has been feared to cause bile reflux. the first 30 mgb patients will undergo a gastroscopy and a hepatobiliary scintigraphy for bile reflux detection at 6 months.

Eligibility criteria:
inclusion criteria: * bmi\>35 exclusion criteria: * pregnancy * previous bariatric surgery * anemia * esophagitis (la b-d) * esophageal intestinal metaplasia

Keywords: roux-en-y gastric bypass mini-gastric bypass single anastomosis gastric bypass
seed movement in prostate brachytherapy implants: clinical measurement and dosimetric consequences

Conditions: Prostate Cancer

Summary: there are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. this study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial ct and mri scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.

prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.

Eligibility criteria:
inclusion criteria: * treated with prostate brachytherapy * low risk or intermediate risk prostate cancer * ambulatory * stable medical condition * 18 years of age or older * capable of informed consent exclusion criteria: * no use of any hormonal therapy * unable to have mri scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.

Keywords: seed movement implants prostate brachytherapy localized
clinical utility study for exo-pdac

Conditions: Pancreas Cancer

Summary: this is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. the purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. the data from this study will be submitted to a national journal for publication. the study plans to enroll up to 250 physicians. upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as clinical performance and value vignettes (cpv®). cpv®s describe patients physicians typically encounter in their daily practice and are not meant to be difficult. in each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of cpv® administration to be approximately 45 - 60 minutes. all responses to the cases will be completed online and will be kept confidential. over 2 cpv® administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. if physicians are randomized to an intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of cpv® administration. they are asked to review these materials before moving to the next cpv® administration round. the time to review educational materials is estimated to be approximately 15 minutes.

Eligibility criteria:
inclusion criteria: * board-certified for at least two years * averaging at least 20 hours per week of clinical and patient care duties over the last six months * routinely evaluate patients at risk for pancreatic cancer in their practice * practicing in the u.s. * english speaking * access to the internet * informed, signed, and voluntarily consented to be in the study exclusion criteria: * non-english speaking * unable to access the internet * not practicing in the u.s. * not averaging at least 20 hours per week of clinical or patient care duties over the last six months * previous exposure to the test * do not voluntarily consent to be in the study
inhaled nitric oxide for pulmonary hypertension and bronchopulmonary dysplasia

Conditions: Pulmonary Hypertension; Bronchopulmonary Dysplasia

Summary: inhaled nitric oxide (ino) is an effective treatment for pulmonary hypertension (ph) in term and near-term infants. preterm infants are at risk for early ph that is associated with high risk for bronchopulmonary dysplasia or death. in multiple clinical trials, ino treatment was not effective for bpd prevention. however, infants were not screened for ph and ino treatment was not targeted for ph. ino treatment for ph in preterm infants is controversial due to lack of evidence. the study team hypothesizes that early diagnosis of ph (72-96 hours of life) and ino treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants. 1. to determine if ino treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or bpd. 2. to determine if ino treatment of extremely preterm infants with early ph will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.

this is a single center, blinded, randomized control clinical trial to evaluate the effects of inhaled nitric oxide on the outcome of survival and incidence of bronchopulmonary dysplasia. this trial has a planned enrollment of 138 infants with 68 infants with delayed pulmonary transition assigned to either the treatment or placebo group. there is no enrollment restriction based on gender, ethnicity, or race. enrollment is expected to take 36 months with an additional 12 months for data analysis.infants with early pulmonary hypertension will be randomized to the treatment or placebo group. treatment will continue until resolution of pulmonary hypertension or through day 14, whichever comes first. serial echocardiograms will be performed every 48 hours +/-12 hours until day 14. oxygen saturation levels will be averaged every 24 hour period following enrollment. this study will provide evidence for the beneficial effects of early diagnosis and treatment of pulmonary hypertension in preterm infants.

Eligibility criteria:
inclusion criteria: step 1: * birth between 23 weeks and 0 days and 29 weeks and 6 days. * positive pressure ventilation at 72-96 hours of age step 2: * early pulmonary hypertension exclusion criteria: step 1: * death prior to 12 hours of age or first echocardiogram * chromosomal anomalies * major congenital anomalies * myocardial dysfunction * complex cardiac defect * dependent on right to left shunting of blood step 2: * excessive pulmonary blood flow (left to right shunt across pda) * pulmonary blood flow obstruction secondary to pulmonary vein stenosis * mitral valve stenosis * cor triata * aortic valve atresia
efficiency and efficacy of the distress thermometer in the burn and wound population (research mentoring high student project)

Conditions: Burns

Summary: the purpose of the study is to test the efficiency and efficacy of the distress thermometer of patients admitted to the tertiary burn and wound center. the american cancer society and the national comprehensive cancer network published treatment guidelines in 2005 adopting the use of the distress thermometer as the preferred adjunct assessment tool of a patient's emotional well-being. a literature search provided extension of the tool to a cardiac follow-up clinic. the distress thermometer is currently used with oncology patients at saint elizabeth. the emotional well being of patients and their significant others is a hallmark of wholistic care. the simple likert scale of 0-10 has a trigger for further assessment and/ or intervention at four. the validity testing of the tool was done against the hospital anxiety and depression scale (hads) and the brief symptom inventory (bsi-18). the purpose of this study is to measure the efficiency and efficacy of the documentation of the distress thermometer to patients admitted to a tertiary burn and wound care center. the frequency of the documentation will be counted and type of documentation will be categorized.


Eligibility criteria:
inclusion criteria: * nursing staff will be nurses working the evening/night shift beginning at 1900. exclusion criteria: * all patients on the ventilator.

Keywords: burn department nursing staff
clinical evaluation of a progressive addition lens (pal)

Conditions: Presbyopia

Summary: the purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients. this evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.


Eligibility criteria:
inclusion criteria: * an ability to comprehend and give an informed consent for participation in the trial * presbyopia exclusion criteria: * concurrent participation in another clinical trial * age\<18 * for female subjects: pregnancy \\ planning a pregnancy \\ lactating at the time of enrollment * imbalanced diabetes \\ high blood pressure \\ thyroid disease * infectious disease * inability (cognitively) to comprehend the instructions given during the trial and to comply with them

Keywords: progressive addition lens multifocal presbyopia
novel risk factors of atrial fibrillation in patients with chronic heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in patients with chronic heart failure.

atrial fibrillation (af) is the most common cardiac arrhythmia in clinical practice. chronic heart failure (chf) has become a major clinical and public health problem. both af and chf often co-exist and complicate each other's administration.several risk factors have been demonstrated to be associated with the risk of af in patients with chf. lopez et al. found that higher levels of low-density lipoprotein cholesterol (ldlc) and total cholesterol were associated with a lower incidence of af independently of other risk factors from the atherosclerosis risk in communities (aric) study. thus the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in patients with chronic heart failure. this study maybe provide a novel opinion on the prevention of af in patients with chf.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic heart failure exclusion criteria: * use of statins

Keywords: lipids atrial fibrillation heart failure
cognitive decline in non-demented pd

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with parkinson's disease (pd).

cognitive dysfunction can occur in early stage of parkinson's disease (pd) and increases as pd progresses. attention deficits in pd patients with dementia strongly predict the impairment of their daily living activities. previous studies have shown that atomoxetine improves pd executive dysfunction and rivastigmine improves attention deficits in pd patients with dementia without worsening the motor symptoms. the aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in pd patients without disabling cognitive impairment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * respond to levodopa therapy exclusion criteria: * dementia * psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or add/adhd * any clinically unstable disease such as cancer, hiv/aids, heart condition, liver disease, kidney or renal failure or others that might require hospitalization * evidence for another neurological disease (history of seizures, alzheimer disease, multiple sclerosis or other movement disorders); * currently using any of the study drugs; * colorblindness

Keywords: attention mild cognitive impairment dementia
greater occipital and supraorbital nerve blockade in migraine patients

Conditions: Migraine Disorders

Summary: the investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.

a mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to gon and son in the blockade patients. placebo patients received 2 ml 0.9% saline in the same way. patients were blinded to kind of injection.

Eligibility criteria:
inclusion criteria: * lack of benefits 1 year from preventive treatment or intolerance to their treatments. * 18 ≥ years old * migraine without aura for more than 1 year, minimum of two or more migraine attacks per month. exclusion criteria: * patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery * allergies to local anesthetics * hemorrhagic diathesis * alcohol or drug abuse

Keywords: pain nerve blocks headache local anaesthetics migraine
structure and function of the gastro-esophageal junction

Conditions: Gastroesophageal Reflux Disease

Summary: aims of research project: to identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging. hypothesis: 1. functional factors including gej function (e.g. sphincter pressure) and proximal gastric distension determine whether or not tlesr occurs; however 2. structural factors including separation of gej anatomy, intra-gastric distribution of the meal and secretions determine whether tlesr is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux'). 3. initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with gord; a medication that inhibits reflux by effects on goj function (study #3) .


Eligibility criteria:
inclusion criteria: study #1: * healthy male and female volunteers * aged at least 18 and not more than 49 y * no history of gastrointestinal symptoms * able to communicate well with the investigators and to comply with the requirements for the entire study * who provided written informed consent before participating in the study, after being given a full description of the trail. study #2 and #3: * male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing * aged at least 18 and not more than 49 y * no history of gastrointestinal symptoms * able to communicate well with the investigators and to comply with the requirements for the entire study * who provided written informed consent before participating in the study, after being given a full description of the trail. exclusion criteria: * with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements * with use of medications influencing upper gi motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics) * with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed * with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3) * suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease * with any evidence of infectious disease * with evidence or history of drug or alcohol abuse * with insufficient knowledge of the german language • who, for any reason, are unable to complete the study

Keywords: gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
evaluation of states in major depressive patients with cancer, hospitalized in a hospital palliative

Conditions: Cancer

Summary: the investigators propose a study that aims to develop a methodology for assessing this risk and the psychological consequences of the malignancy in the palliative phase.


Eligibility criteria:
inclusion criteria: * patient (s) age (s) 18 or more * patient (s) reach (s) of a cancer palliative stage * patient (s) hospital (s) in the palliative care service * patient (s) with cognitive function to an interrogation * patient (s) having a physical condition for an interview lasting 45 minutes * patient (s) that received clear information on the diagnosis and prognosis of their disease. * free and informed consent signed exclusion criteria: * patient (s) age (s) under 18 years * patient (s) under supervision or unable to give informed consent * patient (s) whose cognitive functions do not allow an examination.

Keywords: palliative cares cancer suicide risk